PTN - Palatin Presented Phase 3 Dry Eye Disease Clinical Data at ASCRS 2024

2024-04-08 08:01:14 ET

DENVER, Colo., Apr 08, 2024 ( 247marketnews.com )- Palatin Technologies, Inc. (NYSE: PTN ) presented positive Phase 3 PL9643 MELODY-1 clinical trial results for the treatment of dry eye disease (DED) at the American Society of Cataract and Refractive Surgery (ASCRS) and plans to discuss the regulatory approval path with the FDA this quarter.

“Analysis of our successful Phase 3 MELODY-1 clinical trial results, demonstrate that PL9643 has broad, robust and rapid efficacy for multiple symptom endpoints. The efficacy results were statistically significant for the co-primary symptom endpoint of pain and 7 of 11 exploratory secondary endpoints, including eye dryness, as early as two weeks (the 1 ^st time point measured). The effect improved and maintained statistical significance over the 12-week treatment period,” said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. “Additionally, we have identified a substantial patient population with statistically significant efficacy results after two weeks of treatment with PL9643 for multiple sign endpoints, including all four fluorescein staining endpoints, which improves ocular surface disorders and facilitates the identification and treatment of epithelial damage and corneal injuries.”

“The early onset of efficacy for multiple symptoms and signs of dry eye disease and the excellent ocular safety and tolerability profile positions PL9643 as a highly differentiated product. We are advancing discussions with potential collaboration partners and actively preparing for a meeting with the FDA later this quarter to discuss the remaining studies for the PL9643 program required to support an NDA submission,” Dr. Spana continued.

“Dr. Donnenfeld’s presentation is important, not only because it illustrates PL9643 MELODY-1 positive results in the context of other developmental programs for DED but identifies a potential key differentiating treatment option for dry eye disease in terms of its safety and tolerability profile,” commented Michael Raizman, M.D., Chief Medical Officer at Palatin.

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